BACKGROUND: The injection of low dose buprenorphine to the sympathetic ganglia, termed "GLOA", Ganglionide Local Opioid Analgesia, is used to treat chronic pain in several European centres. It is not known whether the clinically observed GLOA effect in chronic pain syndromes is due to a specific effect of buprenorphine at the ganglia. We assessed whether GLOA, plus intramuscular saline, was more efficacious than the reverse, saline injection to the stellate plus intramuscular buprenorphine, termed SSB. METHODS: We devised a randomized, double-blinded, controlled crossover trial to treat patients with chronic upper body pain syndromes. Patients first received either GLOA or SSB. Pain was assessed using pain diaries both before injection and over the first 8h and 6days afterwards, and was expressed as relative pain intensity post versus pre-injection pain. RESULTS: The median relative pain intensity after injections did not differ between GLOA and SSB. Four patients reported a low, <50%, relative pain level over the first 8h after SSB only. Four patients did not complete the trial and were excluded. One patient with cardiomyopathy became acutely diaphoretic and fatigued after GLOA, his vital signs however remained stable. CONCLUSIONS: We failed to show a superiority of GLOA over SSB. Our results suggest it unlikely that the clinically observed effect after a single GLOA injection is due to a specific action of buprenorphine at the stellate ganglion. The efficacy of GLOA is hereby questioned. The use of GLOA in patients with cardiomyopathy should be cautioned. TRIAL REGISTRATION: ISRCTN59287260; http://www.controlled-trials.com/
RCT Entities:
BACKGROUND: The injection of low dose buprenorphine to the sympathetic ganglia, termed "GLOA", Ganglionide Local Opioid Analgesia, is used to treat chronic pain in several European centres. It is not known whether the clinically observed GLOA effect in chronic pain syndromes is due to a specific effect of buprenorphine at the ganglia. We assessed whether GLOA, plus intramuscular saline, was more efficacious than the reverse, saline injection to the stellate plus intramuscular buprenorphine, termed SSB. METHODS: We devised a randomized, double-blinded, controlled crossover trial to treat patients with chronic upper body pain syndromes. Patients first received either GLOA or SSB. Pain was assessed using pain diaries both before injection and over the first 8h and 6days afterwards, and was expressed as relative pain intensity post versus pre-injection pain. RESULTS: The median relative pain intensity after injections did not differ between GLOA and SSB. Four patients reported a low, <50%, relative pain level over the first 8h after SSB only. Four patients did not complete the trial and were excluded. One patient with cardiomyopathy became acutely diaphoretic and fatigued after GLOA, his vital signs however remained stable. CONCLUSIONS: We failed to show a superiority of GLOA over SSB. Our results suggest it unlikely that the clinically observed effect after a single GLOA injection is due to a specific action of buprenorphine at the stellate ganglion. The efficacy of GLOA is hereby questioned. The use of GLOA in patients with cardiomyopathy should be cautioned. TRIAL REGISTRATION: ISRCTN59287260; http://www.controlled-trials.com/
Authors: Christoph Sproll; Bernd Turowski; Rita Depprich; Norbert R Kübler; Marion Rapp; Julian Lommen; Henrik Holtmann Journal: Case Rep Med Date: 2018-05-24